Radiation induced weight and hair loss are clinical, cosmetic and psychological problems for cancer patients. Hair loss in patients receiving radiation therapy for cranial and extracranial lesions may have major psycho-social consequences for the patient. Where hair loss is due to direct radiation, it is usually irreversible. Attempts to minimize radiation dermatitis and hair loss have been directed at using topical radiation protectant agents (Kim, J. et al., Seminars in Oncology 1983, 10, 86-92; Verhey, L J and Sedlacek, R., Rad. Res. 1983, 93, 175-183); lowering skin temperature in the radiation field (Liebner, E J et al., Am. J. Roent. Rad. Ther and Nucl. Med. 1962, 88, 976-987); applying topical cortisone (Potera, M E et al., Radiology 1982, 143, 775-777); and use of local anesthetics (Ohlsen, L. et al., Acta Oncological 1987, 26, 467-476). The success of these therapies has been minimal and none are in common clinical usage.
Weight loss is a well recognized problem in cancer patients treated with radiation and/or cancer chemotherapeutic agents, and has been shown to be an independent prognostic indicator of decreased survival rates. The cause of this weight loss is believed to be related to both decreased caloric intake/absorption and increased energy requirements. However, it has been found that increased caloric intake has not improved survival for patients with a variety of advanced cancers. Thus, the prevention of weight loss should be considered as an important goal to decrease morbidity and mortality associated with cancer-related therapies.
U.S. Pat. 4,793,996 (Kennedy et al.) discloses a process comprising treating soybeans with acetone, followed by ethanol extraction and acetone precipitation for obtaining Bowman Birk Inhibitor (BBI). The soybeans may be defatted prior to acetone treatment. In addition, BBI may be further purified by conventional techniques. Kennedy et al. discovered that in the conventional process for preparing BBI from soybeans, a factor remained which adversely affected the ability of BBI to inhibit the malignant transformation of cells. If the factor was removed, the resulting BBI product was capable of inhibiting the malignant transformation of cells. It was found to be possible to remove this factor by treating the soybeans with acetone prior to the ethanol extraction step.
Kennedy et al., in U.S. application Ser. No. 824,719 filed Jan. 17, 1992 now U.S. Pat. No. 5,217,717 entitled "Methods of Making Soybean Bowman-Birk Inhibitor Concentrate and Use of Same As a Human Cancer Preventative and Therapy", which is incorporated herein in its entirety, describe methods for producing novel BBI concentrate products. Those BBI concentrate products are employed by the methods of the present invention. The process described to produce those BBI products was found to be economically superior due to the avoidance of an aqueous alcohol extraction step and the use, in certain embodiments, of ultrafiltration as a separation process step.